The Recall Desk
Agency classClass IOur severity:SevereFDA (Food)·F-1148-2020·Announced 2020-08-19

Wellements Iron Drops Sampler Recalled for Undeclared Milk

Wellements LLC is recalling Iron Drops Sampler liquid dietary supplements because the product contains undeclared milk.

The agency’s classification

FDA (Food): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Product contains undeclared milk"

Plain-English summary

Wellements LLC is voluntarily recalling approximately 20,964 bottles of Iron Drops Sampler (UPC 729609000098) liquid dietary supplements. The product is a 1 oz/30 mL amber glass bottle packaged in an individual carton that includes a 1 mL oral syringe dispenser. The recall is being conducted because the product contains undeclared milk.

The affected product is identified by Lot 10592 BB 10/2020. The recall is distributed nationwide, with specific distribution in Arizona, California, Colorado, Connecticut, Florida, Illinois, Indiana, Massachusetts, Ohio, Pennsylvania, South Carolina, Texas, and Wisconsin.

Consumers with this product should stop using it and contact Wellements LLC for further instructions. Individuals with a milk allergy should consult a healthcare provider if they have consumed the product.

The recalled product

Product
Iron Drops Sampler (UPC 729609000098) liquid Dietary Supplement, 1 oz/30 mL, (2 mL fill) amber glass bottle packaged in an individual product carton that includes a 1 mL oral syringe dispenser.
Manufacturer
Wellements LLC
Affected units
20,964

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot 10592 BB 10/2020

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Wellements LLC under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Wellements LLC

See all →

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